Randomized Chemoprevention Trial With 4-HPR (Fenretinide) in Superficial Bladder Cancer
- Determine the efficacy, mechanism of action, and toxicity of fenretinide in patients at
risk of recurrent superficial bladder cancer after complete resection of initial tumor.
- Determine the treatment effects in modulating the expression of retinoid receptors,
chromosomal abnormalities (numerical chromosomal abnormalities and DNA ploidy),
apoptosis, and autocrine motility factor receptor (intermediate endpoint markers of
recurrent disease) in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
lesion type (multifocal vs solitary). Patients are randomized to one of two treatment arms.
Patients receive either oral fenretinide or placebo on days 1-25. Courses repeat every 28
days for up to 1 year in the absence of disease progression, unacceptable toxicity, or
development of a second primary cancer requiring therapy.
Patients are followed every 3 months for 15 months.
PROJECTED ACCRUAL: A total of 178 patients (89 per arm) will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Recurrence rate of transitional cell carcinoma (TCC)
Recurrence rates is defined as proportion of participants who recur within one year of surgery.
Anita L. Sabichi, MD
M.D. Anderson Cancer Center
United States: Federal Government
|Baylor College of Medicine||Houston, Texas 77030|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Veterans Affairs Medical Center - Seattle||Seattle, Washington 98108|